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Long term extension of a randomised controlled trial of probiotics using electronic health records.

Davies, Gareth, Jordan, Sue, Brooks, Caroline J, Thayer, Daniel, Storey, Melanie, Morgan, Gareth, Allen, Stephen ORCID:, Garaiova, Iveta, Plummer, Sue and Gravenor, Mike (2018) 'Long term extension of a randomised controlled trial of probiotics using electronic health records.'. Scientific Reports, Vol 8, Issue 1, p. 7668.

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Most randomised controlled trials (RCTs) are relatively short term and, due to costs and available resources, have limited opportunity to be re-visited or extended. There is no guarantee that effects of treatments remain unchanged beyond the study. Here, we illustrate the feasibility, benefits and cost-effectiveness of enriching standard trial design with electronic follow up. We completed a 5-year electronic follow up of a RCT investigating the impact of probiotics on asthma and eczema in children born 2005-2007, with traditional fieldwork follow up to two years. Participants and trial outcomes were identified and analysed after five years using secure, routine, anonymised, person-based electronic health service databanks. At two years, we identified 93% of participants and compared fieldwork with electronic health records, highlighting areas of agreement and disagreement. Retention of children from lower socio-economic groups was improved, reducing volunteer bias. At 5 years we identified a reduced 82% of participants. These data allowed the trial's first robust analysis of asthma endpoints. We found no indication that probiotic supplementation to pregnant mothers and infants protected against asthma or eczema at 5 years. Continued longer-term follow up is technically straightforward.

Item Type: Article
Subjects: QU Biochemistry > Vitamins > QU 145.5 Nutritive values of food
QW Microbiology and Immunology > QW 4 General works. Classify here works on microbiology as a whole.
WX Hospitals and Other Health Facilities > Hospital Administration > WX 173 Medical records
Faculty: Department: Clinical Sciences & International Health > Clinical Sciences Department
Digital Object Identifer (DOI):
SWORD Depositor: JISC Pubrouter
Depositing User: Stacy Murtagh
Date Deposited: 29 May 2018 12:41
Last Modified: 12 Sep 2019 13:28


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